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TERMINATEDNA

KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

NCT01874730•Duke University

Summary

This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea. The study will be carried out as a prospective, randomized, controlled, multicenter, clinical trial in patients undergoing colorectal surgery. The purpose of this study is to determine if an enhanced recovery strategy paying close attention to the type and amount of fluid given during the surgery with proper monitoring combined with a comprehensive perioperative pain management will have a better post-operative outcome compared to institutional standard of care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®, is an intravenous solution used to treat low blood volume. The Volulyte® solution being used in the study and the monitor used are approved by the Korean Food and Drug Administration

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Elective, open colorectal surgery including sigmoid resections, i.e. with an upper rectal anastomosis and with or without planned stoma. If the planned surgery is a combined procedure, the associated procedure should not add more than 1 hour to the surgery time of the primary colorectal surgical procedure alone.
•2. Both genders; age ≥ 45 years and ≤ 80 years.
•3. ASA Grades I-III
•4. Voluntary participation and signing the informed consent form

Exclusion Criteria

•1. Fluid overload (hyperhydration), especially in cases of pulmonary edema and congestive heart failure, or patients with severe cardiovascular disorders (New York Heart Association, NYHA III-IV)
•2. Patients with significant cardiac arrhythmias or depending on pacemaker
•3. Patients with impaired liver and/or kidney functions (ALT more than 2 times the normal upper limit and/or Serum Creatinine (SCr) more than 2 times the normal upper limit)
•4. Renal failure with oliguria or anuria not related to hypovolemia
•5. Patients receiving dialysis treatment
•6. Patients with non-resectable malignancies
•7. Patients who are non-cooperative or non-communicable
•8. Patients with significant preoperative coagulation abnormalities
•9. Patients receiving treatment with opioids for significant chronic pain
•10. Patients in need of organ transplantation
+7 more criteria

Locations (3)

Samsung Medical Center

Gangnam-Gu, Seoul, South Korea

Yonsei University College of Medicine

Seodaemun-gu, Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Key Dates

Start Date

July 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

August 7, 2015

Enrollment

101

ACTUAL participants

Conditions

Goal-oriented Fluid TherapyColorectal Surgery

Interventions

Combined epidural-general anesthesia (CEGA)

OTHER

Volulyte® (6% HES 130/0.4 in balanced solution)

DRUG

Patient-Controlled Epidural Analgesia (PCEA)

OTHER

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

NCT07464600

Colorectal SurgeryEnhanced Recovery+3 more

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RECRUITINGNA

Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)

NCT07388953

Colorectal CancerColorectal Surgery+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Inclusion Criteria

Exclusion Criteria

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)

Duration of Urinary Catheterization

Preventing Ovarian Cancer Through Oportunistic Salpingectomy at the Time of Colorectal Surgery

The Effect of Virtual Reality Glasses Application on Pain and Anxiety Levels in Colorectal Surgery Patients

POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol